US10786380B2 - Bariatric device and method - Google Patents

Abstract

A bariatric device includes an esophageal member having an esophageal surface that is configured to generally conform to the shape and size of a portion of the esophagus and an anchoring technique anchoring the esophageal member to the portion of the esophagus. The bariatric device includes a cardiac member having a cardiac surface that is configured to generally conform to the shape and size of a portion of the cardiac portion of the stomach and a connector connected with the esophageal member and the cardiac member to cause strain to be applied by the cardiac member to the cardiac portion of the stomach. The strain applied by the cardiac member to the cardiac portion of the stomach causes satiety in the absence of food. The connector is adapted to pass through the gastroesophageal junction while leaving a continuous portion of the gastroesophageal junction substantially unrestrained.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent application Ser. No. 13/965,617, filed Aug. 13, 2013, which is division of U.S. patent application Ser. No. 12/539,112, filed Aug. 11, 2009, now U.S. Pat. No. 8,529,431, which claims priority from U.S. provisional patent application Ser. No. 61/107,511, filed on Oct. 22, 2008, and U.S. provisional patent application Ser. No. 61/159,143, filed on Mar. 11, 2009; and U.S. patent application Ser. No. 12/539,112, filed Aug. 11, 2009, is a continuation-in-part of International Patent Cooperation Treaty Application No. PCT/US08/53912, filed on Feb. 14, 2008, which claims priority from U.S. provisional patent application Ser. No. 60/901,457, filed on Feb. 14, 2007; U.S. provisional patent application Ser. No. 60/921,930, filed on Apr. 5, 2007; and U.S. provisional patent application Ser. No. 60/931,109, filed on May 21, 2007, the disclosures of which are hereby incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

The present invention is directed to a bariatric device and method of causing weight loss in a recipient.

Obesity is a large and increasing problem in the United States and worldwide. In round numbers, from the period encompassing the year 1990 to the period encompassing the year 2000, the prevalence of overweight people (BMI greater than 25) increased from 56 percent of United States adults to 65 percent and the prevalence of obese adults (BMI greater than 30) increased from 23 percent to 30 percent. Likewise, the prevalence of overweight children and adolescents (ages 6-19 years) increased from 11 percent in the period encompassing the year 1990 to 16 percent in the period encompassing the year 2000. The increasing prevalence of excess body mass among children and adolescents will make the problem even greater when they reach adulthood. The problem is not limited to the United States. Between 10 percent and 20 percent of European men are obese and between 10 percent and 25 percent of European women are obese. Numerous medical conditions are made worse by obesity including Type II diabetes, stroke, gallbladder disease and various forms of cancer. Approximately 500,000 people in North America and Western Europe are estimated to die from obesity-related diseases every year and obesity is estimated to affect more than one billion adults worldwide. Therefore, there is a pressing and unmet need for a solution to the epidemic problem.

SUMMARY OF THE INVENTION

The present invention provides a bariatric device and method of causing weight loss in a recipient that fulfills this pressing and unmet need in an effective and minimally invasive manner. A bariatric device and method of causing weight loss in a recipient according to an aspect of the invention includes providing an esophageal member, a cardiac member and a connector connected with the esophageal member and the cardiac member. The esophageal member has an esophageal surface that is configured to generally conform to the shape and size of a portion of the esophagus. The cardiac member has a cardiac surface that is configured to generally conform to the shape and size of a portion of the cardiac portion of the stomach.

Receptors are stimulated in order to influence a neurohormonal mechanism in the recipient sufficient to cause weight loss including positioning the esophageal surface at the esophagus and the cardiac surface at the cardiac portion of the stomach. This causes at least partial satiety by augmenting fullness caused by food and simulating fullness in the absence of food.

The connector may be positioned at the GE junction and be adapted to leave a contiguous portion of the GE junction substantially unrestrained. This contiguous portion of the GE junction may be at least half of the GE junction, may be at least 75% of the GE junction and may be at least 90% of the GE junction. The contiguous portion of the GE junction may be at the angle of His.

The connector may include a tension member, such as a semi-rigid strap. The strap may be positioned within the GE junction opposite the angle of His. The strap may be made substantially of Nitinol.

The connector may include a tether. The tether may extend at least partially external the GE junction. The tether may be connected with the esophageal member and the cardiac member either in situ or external the recipient. The tether may be adjacent the angle of His. A clamp may be provided to secure at least one end of the tether. The clamp may include a body and a plurality of through-openings in the body, the through-openings receiving the tether and allowing one-way movement of the body along the tether. In this manner, the body may be movable in one direction along the tether and resists movement in an opposite direction.

The connector may include a plurality of the tethers. The tethers may be positioned either on a same side of the GE junction or on opposite sides of the GE junction. The tether(s) may be made from (i) substantially non-coated silk, (ii) Ethibond suture, (iii) ePTFE or (iv) an elastic material. The tether(s) may include a tissue attachment surface or a tissue ingrowth surface.

The esophageal member may have a reinforced tether attachment wall portion. The esophageal member may have an outer surface that defines a tissue attachment portion. The esophageal member may include a cage and an impervious cover over the cage. The cage may be formed from an elongated member that is joined at junctions by ferrules. The cage may be made up of an elongated member that is formed as an interwoven spiral. The cage may be covered with at least one flexible sleeve. The elongated member may be a Nitinol wire. Distal and/or proximal end portions of the cage may be flared.

The cardiac member may include a generally planar member defining the cardiac surface. The planar member may include a through-opening adapted to be positioned at the GE junction and a sealing flange surrounding the through-opening. The planar member may include a stiffening mesh and a generally flexible material surrounding the mesh. The planar member may include ribs that provide stiffening to the planar member or may include a surface feature to resist slippage of a deployment tool during tether driving. The cardiac member may be radiopaque in whole or in part.

The esophageal member, the cardiac member and the connector may be defined by an elongated member that is at least partially spirally wound. A surface cover may be provided over at least the esophageal member and the cardiac member. The connector may be defined by a portion of the elongated member that is not spirally wound.

The connector may be longitudinally adjustable. A ratchet mechanism may be provided to provide the longitudinal adjustability to the connector. The ratchet mechanism may be adjustable in situ.

The connector may include an adjustable tether. The adjustable tether may include a filament and a tube surrounding the filament to facilitate lengthwise movement of the filament.

The cardiac member may include a central portion and a surface extending from the central portion. The surface may be compressible toward itself for deployment and biased away from itself. The surface may be defined by lobes that are formed from elongated members.

The bariatric device may be deployed transorally. Manipulation lines may extend from the esophageal member and/or the cardiac member external the recipient to assist in deployment.

The bariatric device may be substantially non-restrictive to food passage.

The amount of stimulation to the receptors may be adjustable, such as by adjusting the connector and/or by selecting the bariatric device from among a plurality of bariatric devices of different sizes.

A unidirectional clamp and method of endoluminally restraining an end of a medical filament includes providing a body having at least three openings in body. An end portion of the filament is passed through two of the at least three openings to form a loop in the filament. A filament end is passed through another of the opening and under the loop.

A bariatric device and method of causing weight loss in a recipient, according to another aspect of the invention, includes providing at least one cardiac member that is configured to stimulate receptors at a portion of the cardiac region of the stomach. An anchor is provided to engage the cardiac region of the stomach to anchor the at least one cardiac member. In this manner, the cardiac member is capable of influencing a neurohormonal mechanism in the recipient.

The at least one cardiac member may define a cardiac surface and the anchor may hold the cardiac surface against the cardiac region of the stomach.

The anchor may be a plurality of anchors that are distributed about the cardiac region of the stomach with the at least one cardiac member applying a force between adjacent ones of the anchors. The at least one cardiac device may be an endless band that applies a contraction force to the plurality of anchors. Alternatively, the at least one cardiac device may be expansion devices, such as expansion springs, that apply an expansion force between adjacent ones of the anchors.

The anchor may include a surface that facilitates tissue attachment and/or tissue ingrowth.

The cardiac member may be configured to the size and shape of the cardiac region of a recipient with altered anatomy, such as a recipient who has undergone a gastric bypass procedure, a vertical banded gastroplasty, a sleeve gastrorectomy, a duodenal switch, or the like.

These and other objects, advantages and features of this invention will become apparent upon review of the following specification in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front elevation of a bariatric device deployed in a recipient;

FIG. 2 is an illustration of a recipient's gastroesophageal (GE) junction in a dilated state with a bariatric device in place;

FIG. 3 is the same view asFIG. 2 with the GE junction in a constricted state;

FIG. 4 is a perspective view of the bariatric device inFIG. 1 prior to deployment;

FIG. 5 is a perspective view of the bariatric device inFIG. 1 as deployed in a recipient as viewed from the angle of His;

FIG. 6 is a rear elevation of the bariatric device inFIG. 1;

FIG. 7 is a proximal view of the bariatric device inFIG. 1;

FIG. 8 is a distal view of the bariatric device inFIG. 1;

FIG. 9 is another distal view of the bariatric device inFIG. 1;

FIG. 10 is an elevation of an esophageal member;

FIG. 11 is a perspective view of an outer sleeve of the esophageal member inFIG. 10;

FIG. 12 is a perspective view of an inner sleeve of the esophageal member inFIG. 10;

FIG. 13 is a perspective view of a tension member;

FIG. 13ais the same view asFIG. 13 of an alternative embodiment thereof;

FIG. 14 is a perspective view of a cardiac member;

FIGS. 15aand 15bare a flowchart of a procedure for deployment of a bariatric device;

FIGS. 16aand 16bare a flowchart of an alternative procedure for deployment of a bariatric device;

FIG. 17 is a perspective view of a bariatric device deployment member;

FIG. 18 is a perspective view of a medical device fixation tool fixing a bariatric device;

FIG. 19 is an elevation of the medical device fixation tool fixing the bariatric device inFIG. 18;

FIG. 20 is an elevation of a tether clamp;

FIG. 21 is the same view asFIG. 19 illustrated with a tether;

FIG. 22 is an enlarged perspective view of the tether clamp device ofFIGS. 19 and 20;

FIG. 23 is a perspective view of an alternative embodiment of a bariatric device deployed in a recipient;

FIG. 24 is a perspective view of the bariatric device illustrated inFIG. 23 taken from a side and distal direction;

FIG. 25 is a perspective view of the bariatric device inFIG. 23 illustrating additional detail thereof;

FIG. 26 is a perspective view of the bariatric device inFIGS. 22 through 24 illustrating additional details thereof;

FIG. 27 is an elevation of an esophageal member of the bariatric device inFIG. 23;

FIG. 28 is the same view asFIG. 27 of an alternative embodiment of an esophageal member;

FIG. 29 is a perspective view of a cage structure used in the esophageal member inFIG. 27;

FIG. 30 is the same view asFIG. 29 of an alternative embodiment of an esophageal member cage structure;

FIG. 31 is a perspective view of an alternative embodiment of a tether;

FIG. 32 is a perspective view of an alternative embodiment of a bariatric device;

FIG. 33 is an elevation of a connector used with the bariatric device ofFIG. 32;

FIG. 34 is the same view asFIG. 33 of an alternative embodiment thereof;

FIG. 35 is the same view asFIG. 33 of another alternative embodiment thereof;

FIG. 36 is the same view asFIG. 33 of yet another alternative embodiment thereof;

FIG. 37 is the same view asFIG. 33 of yet another alternative embodiment thereof;

FIG. 38 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 39 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 40 s a perspective view of another alternative embodiment of a bariatric device;

FIG. 41 a perspective view of another alternative embodiment of a bariatric device;

FIG. 42 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 43 is an enlarged view of a portion of the bariatric device inFIG. 42;

FIG. 44 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 45 a perspective view of the cardiac member of the bariatric device inFIG. 44;

FIG. 46 a perspective view of another alternative embodiment of a bariatric device;

FIG. 47 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 48 is the same view asFIG. 47 including an outer surface cover for the cardiac member;

FIG. 49 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 50 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 51 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 52 is a perspective view illustrating deployment of the bariatric device ofFIG. 51;

FIG. 53 is a perspective view of an alternative embodiment of a bariatric device;

FIG. 54 is a perspective view of deployment of the bariatric device illustrated inFIG. 53;

FIG. 55 is a perspective view of an alternative embodiment of an esophageal member;

FIG. 56 is a perspective view of another alternative embodiment of an esophageal member;

FIG. 57 is a perspective view of an alternative embodiment of a cardiac member;

FIG. 58 is a perspective view of another alternative embodiment of a cardiac member;

FIG. 59 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 60 is a perspective view of the bariatric device ofFIG. 59;

FIG. 61 is a distal view of another alternative embodiment of a bariatric device;

FIG. 62 is the same view asFIG. 61 of another alternative embodiment of a bariatric device;

FIG. 63 is an elevation of a stud used inFIGS. 62 and 63;

FIG. 64 is the same view asFIG. 63 illustrating installation of the stud;

FIG. 65 is a perspective view of another alternative embodiment of a bariatric device;

FIG. 66 is another perspective view of the bariatric device ofFIG. 65;

FIG. 67 is an enlarged perspective view of the esophageal member of the bariatric device ofFIG. 65;

FIG. 68 is an enlarged perspective view of the cardiac member of the bariatric device ofFIG. 65;

FIG. 69 is an enlarged perspective view of an esophageal member of another alternative embodiment of a bariatric device;

FIG. 70 is an enlarged perspective view of the cardiac member of the bariatric device ofFIG. 69;

FIG. 71 is a perspective view illustrating deployment of another alternative embodiment of a bariatric device deployed in a recipient that underwent a vertical banded gastroplasty;

FIG. 72 is a perspective view illustrating deployment of another alternative embodiment of a bariatric device deployed in a recipient that underwent a sleeve gastrorectomy;

FIG. 73 is a perspective view illustrating deployment of another alternative embodiment of a bariatric device deployed in a recipient that underwent a duodenal switch; and

FIG. 74 is a perspective view illustrating deployment of another alternative embodiment of a bariatric device deployed in a recipient that underwent a gastric bypass procedure.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now specifically to the drawings, and the illustrative embodiments depicted therein, a bariatric device, such as an endoluminalbariatric device10 includes anesophageal member12, acardiac member14, and aconnector16 that is connected withesophageal member12 and cardiac member14 (FIGS. 1-14).Esophageal member12 has awall18 defining anesophageal surface20 that is configured to generally conform to the shape and size of a portion of the esophagus, namely, at the abdominal portion of the esophagus adjacent the gastroesophageal (GE) junction. While illustrated as cylindrical in shape,wall18 may be other shapes, such as a portion of a cylinder, or the like.Cardiac member14 includes abody21 defining acardiac surface22 that is configured to generally conform to the shape and size of at least a portion of the cardiac portion of the stomach.Connector16, which is illustrated as a system of connector members, joins the esophageal and cardiac members.Connector16 may include atension member24 which may be a semi-rigid strap which passes through the GE junction.Connector16 may include one ormore tethers26 which may be attached to the esophageal and cardiac members and pass from the esophageal member to the cardiac member outside of the GE junction. As will be described in more detail below, this is accomplished by passingtether26 throughwall18 ofesophageal member12 through the wall of the esophagus, through the wall of the stomach at the cardiac region, and throughbody21 of the cardiac member.

In the illustrated embodiments,connector16 leaves most of the GE junction unrestrained. As best seen by comparingFIGS. 2 and 3,tension member24 may be positioned opposite the angle of His. The portion of the pseudo-sphincter of the GE junction at the angle of His is relatively unrestrained by the connector and can constrict against the remainder of the pseudo-sphincter andtension member24 as best seen inFIG. 3.Tension member24 may include an inwardlycurved portion28 that allows the portion of the GE junction pseudo-sphincter opposite the angle of His to assume a relatively normal posture, again as illustrated inFIGS. 2 and 3. As best illustrated inFIG. 1, tether(s)26 passes outside of the GE junction pseudo-sphincter through the walls of the esophagus and stomach. Once again, the pseudo-sphincter of the GE junction is allowed to constrict in a relatively unrestrained manner because the tether(s) do not significantly interfere with the pseudo-sphincter of the GE junction. Thus,connector16 allows the GE junction to dilate for the passage of food (FIG. 2) and constrict when food is not passing (FIG. 3) in order to resist passage of stomach contents into the esophagus. Also, the GE junction pseudo-sphincter is allowed to function in a relatively normal manner for the purposes of belching, vomiting, and the like.

In the illustrated embodiment, most of the GE junction pseudo-sphincter is allowed to operate without substantial restraint. Indeed, at least 75 percent, and even 90 percent, of the GE junction may be unrestrained in order to function in a relatively normal fashion. In the illustrative embodiment,tension member24 is made of 0.014 inch super-elastic Nitinol sheet. Because the tension member is in the form of a relatively thin semi-flexible strap, it is able to be folded back for the purpose of inserting the bariatric device through the esophagus for deployment, in a manner that will be described in more detail below. Tether(s)26 may be an elongated filament, such as an uncoated silk suture, an Ethibond suture, an ePTFE suture, an elastic line, or the like. As will be described in more detail below, if desired, tether(s)26 may be within a sheath to allow the filament to move lengthwise, for example, to facilitate subsequent adjustment of the spacing between the esophageal and cardiac members to adjust the degree of satiety. An uncoated silk suture may produce fibrous tissue, which may prevent lateral drift of the tether through the tissue at the GE junction. Alternatively, atether126 may be used having a surface that promotes tissue attachment and/or tissue ingrowth (FIG. 31) to prevent lateral drift of the tether.

As will be described in more detail below,connector16 may be generally in tension andcardiac surface22 stimulates mechanoreceptors in the cardiac region of the recipient in order to influence a neurohormonal feedback mechanism of the recipient sufficient to cause the recipient to lose weight. While the precise manner of causing this effect is not completely known, it may result from an increase in the metabolic rate of the recipient and may cause at least partial satiety by augmenting fullness caused by food and simulating fullness in the absence of food, as described in commonly assigned International Publication No. WO 2006/044640 A1 entitled BARIATRIC DEVICE AND METHOD, the disclosure of which is hereby incorporated herein by reference in its entirety. As described in WO '640, this may be accomplished without mechanically restricting the food intake, such as by inserting a restriction device at the esophagus, GE junction, or the like, utilized in prior art bariatric devices.Esophageal surface20 may additionally contribute to satiety and/or increase in metabolic rate, but its primary function is to work in collaboration withconnector16 andcardiac member14 to resist distal migration ofbariatric device10. Also,connector16, particularlytension member24, may apply pressure at a portion of the GE junction and, thereby, assist in generating satiety.

As previously described,cardiac surface22 ofcardiac member14 and the esophageal surface of the esophageal member are configured to stimulate mechanoreceptors at the abdominal portion of the esophagus, the esophageal-gastric junction and/or the cardia of the recipient. The mechanoreceptors stimulated may be tension receptors, which are sensitive to contraction and elongation; stretch receptors, which are sensitive to elongation only; and/or baroreceptors, which are stimulated by change in pressure. This stimulation may be accomplished bycardiac surface22 andesophageal surface20 exerting a strain, such as an outward pressure, typically a generally radial outward pressure, to the wall of the cardiac region of the stomach and the abdominal portion of the esophagus. This may be accomplished, at least in part, by theconnector16 transmitting forces between the esophageal member and the cardiac member to presscardiac surface22 against the cardia. It may also be accomplished, at least in part, by configuring the wall of the esophageal member to create an interference fit with the abdominal portion of the esophagus. The bariatric device may, alternatively, apply an inward force on the abdominal portion of the abdominal portion of the esophagus, the esophageal-gastric junction and/or cardia. The bariatric device may, alternatively, apply a longitudinal force, such as a proximal/distal force, to the abdominal portion of the esophagus, the esophageal-gastric junction and/or the cardia.

The strain exerted by the bariatric device influences receptors of the neurohormonal feedback mechanism of the neurohormonal system, also known as the neuroendocrine system, present at the esophagus and/or stomach to cause weight loss. The strain that influences the neurohormonal feedback mechanism present at the abdominal portion of the esophagus, the esophageal-gastric junction and/or the cardiac portion of the stomach is intended to be relatively consistent over as large an area as reasonably possible. In contrast to prior proposed devices, such as restriction devices, which require that the recipient ingest food in order to influence neurohormonal feedback mechanisms, the embodiments of the bariatric devices disclosed herein is effective in the absence of food. It also augments fullness caused by food.

Tension member24 interconnects the esophageal and cardiac members, as previously described, and may also serve as a location for fastening of the bariatric device, such as to the muscularis at the GE junction, such as by using conventional sutures passed around the strap or by specialized clips (not shown) that can be deployed in situ to connect the strap with the recipient. Tether(s)26 serves to resist distal migration because the tether passes through the esophageal wall and the stomach wall and creates a sort of sandwiching of the esophageal wall and the stomach wall betweenesophageal surface20 andcardiac surface22. This is due, in part, to the upward extension of the cardia at the angle of His to be somewhat parallel to the esophageal wall.Connector16 also serves to bringcardiac surface22 into engagement with the cardia in order to stimulate the neuroreceptors, which are dominant in the cardia. Thus, it is seen thatesophageal member12,cardiac member14, andconnector16 all operate in unison to resist distal migration ofbariatric device10 while causing satiety and thereby weight loss in the recipient.

Cardiac member14 may be made of a generally resilient material having sufficient flexibility to allow it to be compacted to pass through the esophagus while having sufficient rigidity to allow it to transmit strain fromconnector16 to the cardiac region of the stomach. In the illustrated embodiment,body21 ofcardiac member14 is made from a molded silicone, such as 60 durometer LSR silicone with an embedded mesh such as afabric mesh23 of the type that is known in the art, such as a precision woven polypropylene 35.5×35.5 mesh. The mesh increases tear resistance and stiffness.Body21 may include a proximally raisedportion34 defining a flange.Flange34 is configured to fit against the GE junction. This causes food to be directed through-opening36 inbody21 while resisting the food passing betweencardiac surface22 and the wall of the stomach. In the illustrated embodiment,cardiac member14 may be configured to apply a nominal strain on an order of magnitude of 6.5 PSI to the cardia, although the actual pressure may vary depending on installation factors, such as tension on the tether(s), or the like. In the illustrated embodiments,cardiac member14 is configured to engage the cardia and not the fundus of the stomach. The cardia is resistant to dilation due to its structure while the fundus is subject to dilation. Therefore,cardiac member14 stimulates the mechanoreceptors without causing substantial dilation.

Tension member24 may pass through-opening36 and has anextension38 that fastens tobody21 of the cardiac member oppositecardiac surface22, such as by suture material35 (FIG. 13).Grooves37 may be provided to stabilize the suture material.Extension38 may also be attached tobody21 by being inset molded, and/or using fasteners, or the like.Tension member24 additionally includes aproximal extension40 that attaches to wall18 ofesophageal member12 using similar techniques. An alternative embodiment of atension member24′ is illustrated as including an adjustment mechanism39 (FIG. 13a).Adjustment mechanism39 may adjust either the relative angle betweenextension38 andproximal extension40 or may adjust the length ofextension38 relative toproximal extension40.Adjustment mechanism39 may be operable by a physician transorally to adjust the orientation ofcardiac member21 with respect toesophageal member12. This allows the bariatric device to conform to the recipient's anatomy and to apply a desired pressure to the cardiac region of the stomach. Alternatively,adjustment mechanism39 may be adjusted by a control of the type disclosed in International Publication No. WO 2006/044640 A1 entitled BARIATRIC DEVICE AND METHOD, the disclosure of which is hereby incorporated herein by reference in its entirety.

Tether26 may be held in place proximately by a tether clamp, such as abutton98, on an interior surface ofwall18 ofesophageal member12 and may be held in place distally by a tether clamp, such as a T-fastener, against a surface ofbody21 oppositecardiac surface22. In the illustrated embodiment, a T-fastener42 is attached to the distal and of each tether and is passed throughesophageal wall18 andcardiac member body21 utilizing a medical device fixation tool, or tether device,86.Tether device86 is described in detail in commonly assigned International Patent Application No. PCT/US2008/053962, filed on Feb. 14, 2008, entitled MEDICAL DEVICE FIXATION TOOL AND METHOD OF FIXATION OF A MEDICAL DEVICE, and in U.S. provisional patent application Ser. No. 60/901,457 filed on Feb. 14, 2007, and U.S. provisional patent application Ser. No. 60/921,930, filed on Apr. 5, 2007, entitled BARIATRIC DEVICE AND METHOD, the disclosures of which are hereby incorporated herein by reference in their entirety. Suffice it to say thattether device86 may include acardiac support90 that is positioned by ashaft110 within the recipient's stomach.Cardiac support90 may be pivoted between a deployment position aligned withshaft110 and a use position supporting thecardiac member21 by an actuator (not shown) as illustrated inFIGS. 18 and 19. A needle firing actuator, or needle driver,122 is capable of propelling a needle carrying T-fastener42 throughwall18 throughcardiac member body21 and through anopening128 incardiac support90. Alternatively, T-fastener42 can have a pointed end and be driven directly byneedle driver122 throughwall18 andbody21. Once T-fastener42 is through the cardiac member, proximal tension ontether26 will seat T-fastener42 and pullcardiac surface22 against the cardia of the recipient.

Body21 may be formed with a series ofopenings41 at a portion of the body that is opposite fromtension member24. Theneedle driver122 of the tether device may align with one ofopenings41 thereby easing the passage of the tether throughbody21. However, the nature of the material making upbody21 would accommodate passage of the tether withoutopenings21. One or moreradiopaque surfaces43 may be providedopposite tension member24 or theentire body21 could be radiopaque. These allow the physician to visualize the angle ofcardiac surface22 using fluoroscopy to assist in placement of the bariatric device in the recipient. Also, the angle betweencardiac surface22 andesophageal member12 can be visualized if the esophageal member has any metallic or other radiopaque component. This allows the physician to determine if the cardiac surface and esophageal member are too close together, which could risk the bariatric device migrating, or too far apart, which could produce insufficient satiety. Also, a surface feature, such as an indentation and/or raised shoulders, could be formed onbody21 oppositecardiac surface22 that conforms to support90 to assist in maintaining alignment betweensupport90 andbody21 during driving of the needle throughbody21.

Alternatively, abariatric device10′ may be provided in which tether clamps in the form ofbuttons98 are applied to tether(s)26 after needles attached to tether(s)26 passes throughwalls18 and21 and the recipient's esophageal wall and stomach wall in a manner that will be explained in more detail below (FIGS. 23-26).

Esophageal member12 may include acage44, and animpervious wall45 coveringcage44.Wall45 may be provided by aninner sleeve46, and anouter sleeve48 covering cage44 (FIGS. 10-12). Apad47 made from a tissue attachment or tissue ingrowth material may be provided onesophageal member12 where the tethers enter the esophagus to long-term attachment.Pad47 may be made of a polypropylene mesh.Cage44 may be made from anelongated member50, which, in the illustrated embodiment, is an elastic member, such as Nitinol wire.Member50 is formed as an interwoven spiral, as illustrated inFIG. 10. Alternatively,esophageal member12 may utilize acage144 in which the elongated member is formed as a lattice and joined at adjacent points, such as by ferrules52 (FIGS. 27-29). Distal ends54 ofelongated members50 may formdistal tines54 to resist distal migration ofesophageal member12.Esophageal member12 may be outwardly flared proximally, in order to ensure contact with the esophageal wall, and may be outwardly flared distally in order to assist the engagement oftines54 at the wall of the organ, such as the thick musculara adjacent the GE junction.Tines54 may be slightly outwardly extending in order to ensure penetration of the organ wall. In the illustrated embodiment,tines54 have a length of approximately 1.5 mm.

An alternative embodiment of acage44′ is made from anelongated member50′ that is formed into the three-dimensional structure without the requirement for separate ferrules to join adjacent portions of the structure (FIG. 30). This is accomplished by inter-looping the elongated member at adjacent portions, as illustrated at52′. In the embodiment illustrated inFIG. 29,cage44′ does not include tines at a distal end portion thereof. Other embodiments will be apparent to the skilled artisan. For example, a circumferential ring (not shown) may be provided at a proximal portion ofcage44,44′ in order to provide for the transfer of axial forces around the perimeter of the cage. This may be useful, for example, in order to provide a grasping member should it be desired to remove the bariatric device, reposition the esophageal member, or the like. Due to the structure ofcage44,44′, a proximal force placed upon a proximal end thereof should result in a reduction in diameter in the cage that would allow the cage to be pulled into an overtube of the type that is known in the art. Once in the overtube, the esophageal member could be rotated or repositioned proximally or distally or the bariatric device removed. An alternative embodiment of acage144′ includes a portion ofelongated member50 that is looped distally to define a tether attachment portion ofwall18. The purpose ofloop50 is to provide reinforcement to wall18 to support attachment of the tether(s).

Esophageal member12 may include aninner sleeve46 and anouter sleeve48 overcage44,144,144′ (FIGS. 11 and 12) definingwall18. Each sleeve in the illustrated embodiment may be made of 0.005 thickness of silicone and may include anouter taper56 proximally and/or distally in order to conform to the shape ofcage44,44′. Withinner sleeve46 andouter sleeve48 positioned over the cage, the sleeves may be joined. The inner and outer sleeves may be fused, or laminated, at all points where possible within the openings of the cage. In an alternative embodiment, inner andouter sleeves46,48 may be fused at smaller fusion areas which are smaller than the respective opening in the cage. This may be accomplished, by way of example, by forming an opening at corresponding portions of the inner and outer sleeves and fusing the sleeves at that area, such as by the use of a biologically compatible adhesive, such as a silicone adhesive, or the like. The amount of fusion, or lamination, may affect the amount of rigidity of the esophageal member in resisting lateral forces. This may be used, in combination with the structure of the cage and the diameter of theelongated member50 to adjust the amount of strain placed by the esophageal member on the esophagus by the esophageal member. Although illustrated as made from Nitinol wire, esophageal, the cage may be made from other material, such as a polyetheretherkeytone polymer (PEEK), carbon fiber filament, or the like.

In the illustrated embodiment,esophageal member12 is between 1.8 cm and 2.1 cm inner diameter with 2.2 cm flare at the proximal end portion. It may have a length of between 2 cm to 3 cm or more if needed for anchoring. However, a shorter length tends to reduce the likelihood of food forming an obstruction in the esophageal member. It should be understood that size may vary as a function of the size and anatomy of the recipient.Esophageal member12 and/orcardiac member14 may be affixed in whole or in part using the mucosal capture technique disclosed in commonly assigned International Application No. PCT/US08/53797 filed on Feb. 13, 2008, entitled MUCOSAL CAPTURE FIXATION OF MEDICAL DEVICE, the disclosure of which is hereby incorporated herein by reference in its entirety.

A bariatricdevice deployment procedure70 may be used to deploy bariatric device10 (FIGS. 15aand 15b).Deployment procedure70 begins at71, with the recipient sedated or anesthetized, by performing an esophageal gastroduodenoscopy (EGD) to inspect the recipient's esophagus and stomach and to pass a conventional EGD wire through an EGD scope into the stomach (72). The physician may inject contrast die at one side of the GE junction in order to assist in fluoroscopic visualization and the placement of the bariatric device. The EGD scope is removed and the wire is left in the recipient's esophagus.

The wire may be used to pass a lubricateddeployment device74, as seen inFIG. 17, into the stomach utilizing fluoroscopy (73). The wire may be removed. The cardiac member is deployed distally at75 utilizing a pusher inserted withindeployment device74. Because of the nature of the cardiac member, it will unfold once it is clear of the deployment device. The physician can use amarker68 on the deployment device to align the bariatric device by rotation of the device untilmarker68 is appropriately positioned. Alternately, the physician could rotate the device untiltension member24 either aligns with or is opposite the contrast die mark. With the cardiac device deployed in the stomach, the physician pulls back on thedeployment device74, which pulls the cardiac member against the cardia and deploys the esophageal member from the deployment device. The deployment device is then removed from the recipient (75).

A conventional overtube may be positioned over a conventional endoscope and deployed in the recipient's esophagus distally to the proximal end of esophageal member12 (76). The overtube provides a pathway to the bariatric device to allow completion of deployment while minimizing risk of damage to the recipient's esophagus.

A tether assist device86 (FIGS. 18 and 19) may be inserted through the overtube at78. The tether assist device includes acardiac support90 that is deployed in a manner which will be described in more detail below (79). The tether assist device is actuated to drive needles connected with the tether filament through thewall18 of the esophageal member, the wall of the recipient's esophagus, the wall of the recipient's stomach at the cardia, andbody21 of the cardiac member (80). The cardiac support is then retracted and the tether assist device is withdrawn at81.

The distal end(s) of the tether filament(s) may be secured against the surface ofcardiac member body21 opposite thecardiac surface22 by applying a proximal force to the tether untilintegral tether clamp42 is againstbody21 of the cardiac member. If a separate distal tether clamp is applied in situ, this may be accomplished by inserting an endoscope E through the overtube and through the esophageal member into the recipient's stomach to grasp and withdraw the tether end(s) external to the recipient (82). Alternatively, tether assistdevice86 may retain the tether distal end(s) with the cardiac support so that withdrawal of the tether assist device also withdraws the tether end(s) external to the recipient. A tether clamp, such as abutton98, (FIGS. 23 and 25) may be fixed to the distal end of the tether filament(s) and the proximal end of the tether filament(s) pulled in order to position the tether clamp against the cardiac member (82). Another tether clamp, such as abutton98 may be attached to the proximal end of the tether(s), such as by a slipknot, as will be described in more detail below, and the clamp slid against the wall of the esophageal member, such as by using a knot pusher (83). The knot pusher may have a tapered end to ensure that the button may be pushed entirely against the wall of the esophageal member. Optionally, if more than one tether filament is used, the physician may tie the proximal ends of the tether filaments together and, using a knot pusher, slide the knot against the tether clamp at the esophagus. Excess tether filament may be trimmed and the overtube withdrawn at84.

In an alternative embodiment (FIGS. 16aand 16b), in which the tether(s) is positioned in the recipient before the bariatric device is deployed, a bariatricdevice deployment procedure88 begins with an EGD being performed (89) and an overtube being positioned over an endoscope and deployed to the proximal to the GE junction (91). The tether assist device is inserted through the overtube (92) and operated to deploy the cardiac support (93). The tether assist device is then operated at94 to drive the needle(s) through the walls of the esophagus and the cardia. The tether assist actuator is operated at95 to retract the cardiac support and to withdraw the tether assist device.

The tether needle(s) are withdrawn through the overtube to a location external the recipient (96). The bariatric device may be affixed to both ends of the tether(s). In particular, the proximal end of the tethers is inserted through openings in the esophageal member. The distal ends of the tether(s) are passed through the cardiac member and affixed to the cardiac member, such as using abutton98 as previously described. The bariatric device may then be positioned in the deployment device at97 and the wire is used to pass the deployment device into the stomach with fluoroscopic assist. While the bariatric device is being deployed to the stomach, the physician takes up slack in the tether(s) by pulling on the proximal ends thereof.

The cardiac member is deployed (99) and the esophageal member is deployed (100) in a manner similar to that previously described. When slack is removed from the tether(s), the physician may attach a button to the proximal end of the tether(s) at101 and slides the button(s) against the wall of the esophageal member, such as using a knot pusher. Appropriate tension is applied. If more than one tether is used, the physician may optionally tie the proximal ends together and slide the knot against the esophageal button. The esophageal member may then be anchored (102), as previously described, and excess tether material trimmed (103). Although two (2) tethers are illustrated, one or more than two may be used. If more than two tethers are used, they can be attached to the esophageal member and the cardiac member in a manner that distributes the force both laterally and longitudinally on each member.

Thus, it is seen that bariatricdevice deployment procedure70,88 is minimally invasive and can be performed transorally utilizing many tools that are conventionally used for EGD and endoscopy. The deployment procedure can be performed in a relatively short time, on the order of magnitude of the time required for an endoscopy, colonoscopy, or the like, such as less than one hour and even less than half an hour or less. Because the recipient is sedated, or minimally anesthetized, the recipient should tolerate the procedure much better than a more invasive procedure, such as gastric bypass surgery or other bariatric surgery. It should be understood, however, thatbariatric device10 can be deployed utilizing other techniques. For example, tethers26 can be deployed utilizing a combination of laparoscopic and endoscopic procedures carried out with conventional instruments, rather than utilizing the tether assist device disclosed herein.

Deployment device74 includes a tubular member106 which may have a wall made of 1/32 inch PTFE with a cross section that is smaller than the recipient's esophagus, such as 11/16 inch outer diameter, and having a tapereddistal end108 to reduce a tendency to snare the esophagus while being inserted (FIG. 17).Bariatric device10 may be folded withcardiac member14 rolled andesophageal member12 radially compressed.Tension member24 may be flexed to position the esophageal and cardiac members in the deployment device in the position illustrated inFIG. 11. Aballoon69 may be inserted in the deployment device and inflated to further enhance the smooth contours of the delivery system. During deployment, tubular member106 is lubricated and, as previously described, inserted into the stomach over a previously placed wire and guided using fluoroscopy. Once in position,balloon69 can be deflated and the cardiac member may be deployed by an instrument inserted into the proximal end of the tubular member until the cardiac member exits the tube, at which time it will unravel to its deployed position. With the physician moving the deployment device proximally, thecardiac surface22 will be moved into contact with the cardia and the esophageal member will begin to be deployed out the distal end of tubular member106. Further proximal motion of the tubular member will fully deploy the esophageal member in the esophagus. Should it be desired to reposition the bariatric device, the physician can insert an overtube into the esophagus in a conventional manner, such as over an endoscope, and grasp a proximal end ofcage44,144,144′ in order to reduce the diameter of the cage and position the overtube over theesophageal member12. The bariatric device can then be rotated or, otherwise, moved and redeployed out of the end of the overtube.

Other deployment devices may be utilized. For example, rather than being confined within a tubular deployment tool, the bariatric device esophageal member and cardiac member may be compressed and retained in a compressed state by a cord wound around the members. Once in position, the cord can be removed from around each of the members by pulling on a cord to deploy that member, which then assumes its expanded state. Alternatively, the bariatric device members could be compressed at their respective positions on the tether assist device, with the cardiac member compressed aboutcardiac support93 and the esophageal member compressed about the shaft of the tether assist device. In this manner, both the bariatric device and the tether assist device can be deployed simultaneously through an over-tube and the bariatric device expanded in the proper orientation to the tether assist device by pulling on the cord. This allows the physician to orient the bariatric device in the recipient by orienting the tether assist device.

One ormore lines66a,66b, may be attached to the esophageal member and extend proximally outside the recipient to allow the physician to snug the bariatric device against the cardiac portion of the stomach. Anotherline66cmay be attached tocardiac member21 and extend proximally through the esophageal member external the recipient.Line66callows the physician to positioncardiac member21 laterally and to hold it in place while the tethers are being applied. Lines66a-66bmay be made from sutures and may be color-coded. Oncebariatric device10 is fully deployed,lines66a,66bare severed at the device using endoscopic scissors, or the like.

While the tether clamp for the distal end of the tether(s) can be secured to the tether(s) external the recipient and drawn into position against the cardiac member or can be a fastener integrally formed with the distal end of the tether and driven to position by the tether tool, the proximal end of the tether(s) may be secured by atether clamp98 external the recipient and slid into engagement with the inner wall of the esophageal member along the tether filament once the bariatric device is deployed.

In the illustrative embodiment, the tether clamp may be abutton98 in the form of adisk130 containing a plurality, such as three (3), through-openings132.Disk130 may be made of a suitable material, such as polycarbonate, or the like. As illustrated inFIGS. 21 and 22,tether clamp98 is attached to the proximal end of the tether by passing anend26aof the tether under aloop26bformed by the tether thereby forming a one-way clamp that operates similarly to a slipknot. This allows the tether clamp to be propelled along the tether from external the recipient to a position engaging the inner wall of the esophageal member and snugged up to a desired tension of the tether, using a conventional knot pusher, or the like. Although the tether clamp can move relatively freely in one direction for deployment, it resists movement in the other direction, thereby firmly engaging the inner wall of the esophageal member or cardiac member. A roughenedportion133 of thesurface131 ofdisk130 may be provided to help lock the tether to resist movement oftether clamp98. Also, an elongated extension of surface131 (not shown) may be provided on either side of opening132 to trap or pinch theend26aof the tether.Tether clamp98 causes tension between the esophageal member and the cardiac member via the tether, thereby both engaging the cardiac surface with the cardiac region of the stomach in order to activate receptors in the cardia, as well as to assist in anchoringbariatric device10 in place. For additional stability, the physician may choose to tie a slipknot to the ends, if more than one tether is used, and slide the slipknot against thebuttons98 within the esophageal member using a knot pusher. The ends of the tether are trimmed and removed. The overtube can then be removed.

Once deployed,bariatric device10 may be removed by inserting a conventional overtube in the esophagus and using endoscopic scissors, laparoscopic scissors, or the like, to clip the tether(s). The proximal portion of the esophageal member may be grasped, such as with a conventional grasping tool and pulled proximally. This reduces the diameter of the esophageal member allowing the esophageal member to fit within an overtube. The overtube may be moved distally around the esophageal member, thereby protecting the esophagus and GE junction as the remainder of the bariatric device is retrieved through the overtube. The entire overtube may then be removed, completing the removal procedure. If tissue apposition is used, a conventional ablation procedure may be used to remove the ingrown tissue, such as mucosa, to allow the bariatric device to be moved. Alternatively,bariatric device10 may be made from bioabsorbable material and absorbed in the recipient's body.

Because of the use of the tether(s) and tissue ingrowth for anchoring,bariatric device10 may be left in place for many months and even a year or longer. Becausebariatric device10 can be deployed for longer than just a few weeks, morbidly obese recipients can usebariatric device10 to lose all or most of their excess bodyweight. The recipient may be provided with nutritional counseling in order to develop healthier eating habits during the period of satiety induced bybariatric device10. Tension on the tether(s) and/or tension may be adjusted after deployment as needed to titrate the amount and rate of weight loss. Tension on the tether may be increased by slidingbutton98 while grasping the tether or may be reduced by loosening or replacing the tether. As with any weight loss regiment, recipient's medications should be adjusted to account for the weight loss.

Although illustrated for use in deployment ofbariatric device10, tether clamps98 may find other applications. Examples of such other applications include closure of fistulas, tightening of anastomosis, closure of leaks, tightening of a gastric pouch and closure of a gastrotomy. Other applications will be apparent to the skilled artisan.

An alternative embodiment of abariatric device10′ includes anesophageal member12′ having a conically shaped proximal portion and acardiac member14′ (FIGS. 23-26).Bariatric device10′ includes aconnector16′ made up of atension member24 and a plurality oftethers26.Tethers26 are radially spaced apart in order to provide additional upward pressure on the cardiac member. Also, the force acting on each tether is reduced in order to reduce the likelihood of breakage and to provide redundancy should one of the tethers break.

An alternative embodiment of abariatric device10″ may include aconnector16″ having atension member24 and atether26 including ananchor60.Anchor60 may be made up of anelongated member62 having anouter surface64 that is configured to promote tissue attachment, tissue ingrowth and/or mucosal capture (FIGS. 32 and 33). Examples of such surface configuration are disclosed in commonly assigned International Patent Application Publication No. WO 06/044640A1, entitled BARIATRIC DEVICE AND METHOD and in commonly assigned provisional patent application Ser. Nos. 60/901,457 and 60/921,930 entitled BARIATRIC DEVICE AND METHOD by Baker et al., the disclosures of which are hereby incorporated herein by reference.Anchor60 extends from the lower esophagus to the cardiac region of the stomach through a passage extending outward of the GE junction. As previously described, this allows normal functioning of the GE junction.Elongated member62 has a through-opening, orlumen63, that facilitates passage oftether26. This ensures that the tether will not experience lateral migration. Also, the tether may be allowed to move longitudinally to provide adjustability to the strain exerted by the esophageal and/or cardiac portions.Bariatric device10″ also includes acardiac member14″ having a plurality ofribs30 that are spaced radially aboutbody21″ in order to impart additional stiffness tobody21″ if desired. Also,body21″ may include a surface feature31 that is recessed to the approximate footprint ofcardiac member support90 to enhance engagement ofsupport90 withbody21″ during tether deployment

In use,anchor60 can be positioned by the physician either as part of the procedure to deploybariatric device10″. Alternatively,anchor60 can be positioned several weeks before placement of the rest of the device. This allows time for tissue ingrowth to take place to firmly hold the anchor in place. When the rest of the device is subsequently positioned, the physician can rely on the anchor being firmly positioned.

In another embodiment, ananchor160 includes anelongated member162 having anouter surface164 that is configured to promote tissue attachment, tissue ingrowth and/or mucosal capture (FIG. 34).Anchor160 further includes one ormore attachment mechanisms65, which is illustrated as a loop but may be other configuration that allows attachment toelongated member162, such as by a fastener, or the like.Anchor160 is illustrated without a lumen but may have one depending upon the application. With one ormore anchors160 positioned in the manner previously described, it may serve as a mechanism for attachment of a cardiac portion. The anchor(s) allow strain to be placed on the cardiac region of the stomach by a fastening system between the cardiac portion and theattachment mechanism65. This facilitates a bariatric device having primarily only a cardiac member. Because the bariatric device does not pass at all through the GE junction, there is no interference with normal function of the GE junction. Also, there is no need for engagement with the esophagus.

While described as applying an outward force on the cardiac portion of the stomach, the bariatric device may, alternatively, apply an inward force on the cardia as would be apparent to the skilled artisan. This may be accomplished in various fashions, such as by providing tissue attachment, tissue ingrowth and/or mucosal capture openings on the cardiac member.

In another embodiment, ananchor260 includes anelongated member262 having one ormore appendages58 extending from an outer surface264 (FIG. 35).Appendages58 are configured to promote tissue attachment, tissue ingrowth and/or mucosal capture. This allowsappendages58 to become firmly attached in the wall of the stomach and/or esophagus, thus retaininganchor260.Outer surface264 may optionally include tissue attachment, tissue ingrowth and/or mucosal capture openings.

In yet another embodiment, ananchor360 includes anelongated member362 havingplates57 at one or more ends of the elongated member (FIG. 36). Eachplate57 includesmucosal capture openings59. The mucosal capture openings may be evenly spaced or may be in pairs to promote mucosal bridging. Onceanchor360 is positioned, the mucosa of the esophagus bulges theopenings59 of oneplate57 and the mucosa of the stomach bulges theopenings59 of theother plate57. This mucosal capture provides a more rapid retaining ofanchor360 in position as disclosed in the '457 and '930 provisional patent applications. The mucosal capture can be expedited by using agents to promote scaring together of the mucosal portions across the bridge, such as by fibrosis growth. In the illustrated embodiment, a retainer, such as a cap,55 may be provided to fit over eachplate57 after the mucosa entersopenings62. This applies a pressure on the mucosa to retain the mucosa and may further force the mucosa together to stimulate bridging together of the mucosa.Caps55 can be retained onplate57, such as by snap fit or other known techniques.

Anchor360 may be removable. This is accomplished because the captured mucosa can be removed, such as by ablation, chemical cautery, ultrasound, laser, or the like. One or bothplates57 can be made removable fromelongated member362. This allowsanchor360 to be removable and, hence, the method reversible notwithstanding the use of mucosal capture.

In another alternative embodiment, ananchor460 has anelongated member462 made ofcomplementary sections462aand462b(FIG. 37). These sections snap together in a lengthwise adjustable fashion, such that one section may be inserted from the esophagus and one section from the stomach. Once engaged, further pressure causes a snap retention of the sections together to a desired length. Optionally, the length may be elongatable as well. Each section642aand642bmay include aplate57 or an attachment mechanism (not shown).

An alternativebariatric device134 includes anesophageal member136, acardiac member138 and a connector140 (FIG. 38). Inbariatric device134,connector140 is a strap that is sufficiently rigid to properly positioncardiac member138 against the cardia without the requirement for a tether or other connecting member. However, a tether may also be used.

An alternativebariatric device142 includes anesophageal member144, acardiac member146, and a connector148 (FIG. 39).Connector148 is X-shaped with the center of the X positioned at the pseudo-sphincter of the GE junction. This allows the tension force to be distributed around more of the circumference of theesophageal member144 and thecardiac member146. As withbariatric device134, theconnector148 forbariatric device142 is a single-strap assembly that may be used with or without the use of a tether.

An alternativebariatric device149 includes anesophageal member150 and a cardiac member154 (FIG. 40).Esophageal member150 may includetissue ingrowth openings152 distributed along substantially the entire surface of the wall defining the esophageal member. This promotes tissue ingrowth along substantially the entire inner surface of the esophageal member.Bariatric device149 includes a connector made up of two ormore tethers153 placed opposite each other across the GE junction. The tethers pass external the GE junction and allow substantially unrestrained operation of the pseudo-sphincter. Although only twotethers153 are illustrated, more may be used and distributed around the GE junction.

An alternativebariatric device166 and an alternative embodiment of a deployment procedure forbariatric device166 include acardiac member168 and anelongated shaft170 for positioning the cardiac member against the cardia (FIG. 41). Proximal force onshaft170 causes a bulge to be created at the GE junction to facilitate deployment of one or more tethers. An alternative tether assistdevice172 is shown placing a tether needle through the GE junction and engagingcardiac member168. Once the tether(s) is attached tocardiac member168, theshaft170 can be removed and any esophageal member (not shown) positioned in the esophagus and connected with the tether(s).Tether deployment device172 may be used as shown or in combination with a vacuum to draw in the tissue of the GE junction in order to produce a bulge facilitate firing the tether pin through the tissue.

An alternativebariatric device174 includes anesophageal member176, acardiac member178, and aconnector180 that is adjustable (FIGS. 42 and 43).Connector180 includes an adjustment system, such as a strap,182 connected withcardiac member178 and anadjustment mechanism184 at the esophageal member that adjusts the relative position ofesophageal member176 with respect to the strap. It would be understood by the skilled artisan that strap182 could be fixed toesophageal member176, and theadjustment mechanism184 fixed atcardiac member178.Connector180 allows the position of thecardiac member178 to be adjusted relative to the esophageal member. This allows the amount of strain applied to the cardia to be increased or decreased afterbariatric device174 is deployed. This allows the amount of satiety to be adjusted if the recipient is experiencing too much or too little satiety. Also, adjustment may be made at the time of deployment ofbariatric device174. Alternatively,connector180 may be adjusted by a control of the type disclosed in International Publication No. WO 2006/044640 A1 entitled BARIATRIC DEVICE AND METHOD, the disclosure of which is hereby incorporated herein by reference in its entirety.

An alternativebariatric device186 includes an esophageal member188, acardiac member190 and a connector192 (FIGS. 44 and 45).Cardiac member190 is a ring-shaped member. As best seen by comparingFIG. 44 andFIG. 45,cardiac member190 may be compressed in length during deployment and elongated after being deployed to the stomach. This may not only ease deployment ofcardiac member190, but also may allowcardiac member190 to apply strain in the form of elongation to the cardiac region in addition to pressure against the cardiac region.Connector192 may be made up of a plurality of tethers that are placed inside of the GE junction, although they could also be placed external of the GE junction in a manner previously described. Because of their flexibility and placement, tether(s)192 leaves a continuous portion of gastroesophageal junction substantially unrestrained.

An alternativebariatric device194 includes acardiac member196 that may be similar to cardiac member190 (FIG. 46). However,cardiac member196 may be anchored to the cardia, such as by utilizing an anchor, such as a spiral tacker,198 engaging the cardia, or the like. This applies shear force to the cardia, thus stimulating both the tension receptors and the stretch receptors more directly. While not shown,bariatric device194 may optionally include an esophageal member and a connector between the esophageal member and thecardiac member196.

An alternativebariatric device200 includes anesophageal member202, acardiac member204, and aconnector206 that are commonly formed from an elongated member208 (FIG. 47).Elongated member208 is formed into a spiral to formesophageal member202, is axially extending in order to formconnector206, and is formed into another spiral in order to formcardiac member204.Elongated member208 may be a wire, such as a Nitinol wire, a carbon filament, or the like. As best seen inFIG. 48,esophageal member202 and/orcardiac member204 may be covered with a sleeve, such as silicone, in order to form a substantially smooth external surface in order to reduce erosion to the recipient's esophagus or cardia.

An alternativebariatric device210 may include anesophageal member212, acardiac member214, and a connector216 (FIG. 49).Cardiac member214 may be made from a relatively planar member that has memory, whereby the planar member may be collapsed to pass through the recipient's esophagus and self-expanded to the shape illustrated inFIG. 49 in order to engage the cardia.

An alternativebariatric device220 is in the form of a disk-shapedbody222, which is fastened to the cardia by anchors atpoints224 around its perimeter (FIG. 50). Such fastening may be in the form of a spiral tacker, or other anchor. The presence of periphery anchoring is to provide shear strain as well as pressure strain to the cardia. An esophageal member and connector may optionally be used.

An alternativebariatric device226 is made up of a series of articulatedsegments228, which can be deployed in a linear fashion as illustrated inFIG. 52, but which form a ring-shaped device upon deployment, as illustrated inFIG. 51.Segments228 can be interconnected by living hinges230, which may be biased into the circular orientation ofFIG. 51. The segments may be deployed through adelivery tube232.

An alternativebariatric device234 includes an esophageal member (not shown), acardiac member236, and aconnector238 that connects the esophageal member and the cardiac member (FIGS. 53 and 54).Connector238 is made up of one or more straps that are removable. This allows the physician to substitute a strap having more or less flexibility for another strap. This allows the stiffness of the connector to be tailored to the recipient as well as adjusted after a period of time, as needed. Also, different length straps may be substituted. Aninsertion tool240 may be provided in order to insert the strap into thecardiac member236 and the esophageal member (not shown).

An alternativeesophageal member242 includes a series ofperipheral tines244 that assist in anchoring the esophageal member in the tissue at, or adjacent to, the GE junction (FIG. 55).

An alternativeesophageal member246 is anchored at or adjacent the GE junction by a series of barbs orstaples248 that are applied after the esophageal member is deployed (FIG. 56).

An alternativebariatric device250 has a cardiac surface that is made up of a series ofleafs252 that are interconnected by acentral ring254.Leafs252 are spring-biased into the position illustrated inFIG. 57, but may be folded for deployment. Theleafs252 are illustrated as being formed from an elongated member, such as Nitinol wire. They may be covered by a sleeve, or the like, in order to reduce mucosal erosion.

An alternativebariatric device256 is similar tocardiac member250 except thatleafs258 are formed from a continuous elongated member, such as Nitinol wire (FIG. 58). However,leafs258 may be folded for deployment and self-expand to the form shown inFIG. 40 after deployment.

An alternativebariatric device270 is in the form of a series of pressure patches272 (FIGS. 59 and 60). Eachpressure patch272 includes aresilient disk274 and ananchor276. The anchor is configured to engage the cardia and press the disk against the cardia. This allows eachpressure patch272 to stimulate a portion of the cardia by applying pressure to the cardia.Anchor276 may be in the form of a spiral fastener, although others would be apparent to the skilled artisan.

Abariatric device310 according to an alternative embodiment may, alternatively, apply a stretch force, such as a proximal/distal force, to the abdominal portion of the esophagus, the esophageal-gastric junction, and/or the cardia. In the illustrative embodiment,bariatric device310 includes a plurality of anchors, or studs,311 positioned about or around the cardiac region CR of the stomach (FIG. 61).Bariatric device310 additionally includes a cardiac member in the form of aband312 which applies a lateral force againststuds311. Band312 may be elastic and stretched upon application to apply a laterally inward force onstuds311, as illustrated inFIG. 61. Alternatively,band312 may be elastic and compressed upon application to apply a laterally outward force onstuds311. An optional mechanism, such as a clip, or the like, may be used to holdband312 tostuds311. Studs may be generally stiff or may be flexible according to the application.

In the illustrated embodiment, eachstud311 has apost313 extending into the stomach and a support, such as amesh314 anchored in the stomach wall. The mesh may have tissue ingrowth, tissue attachment or mucosal capture openings to promote fixation to the mucosa, submucosa and/or muscularis. The studs may be applied in a separate procedure before theband312 is applied to allow time for the studs to be firmly supported. Alternatively, studs may be provided as disclosed in U.S. Pat. No. 6,991,643 B2 entitled MULTI-BARBED DEVICE FOR RETAINING TISSUE IN APPOSITION AND METHODS OF USE and U.S. Pat. No. 7,160,312 B2 entitled IMPLANTABLE ARTIFICIAL PARTITION AND METHOD OF USE, the disclosures of which are hereby incorporated herein by reference.Studs311 may be deployed using a pointeddeployment tool316. This may be accomplished endoscopically.

Another alternativebariatric device410 is similar tobariatric device310 in that it utilizes a plurality of anchors, or studs,311 positioned about the cardiac region CR of the recipient. A cardiac member in the form of a series of expansion members, such as expansion springs412, may be applied betweenadjacent studs311 to apply a lateral force to the studs to apply a strain to the cardiac region to stimulate receptors there.

Another alternativebariatric device10″′ includes anesophageal member12′″ and acardiac member14′″ that may be made of a generally resilient material having sufficient flexibility to allow it to be compacted to pass through the esophagus while having sufficient rigidity to allow it to transmit strain from aconnector16′″ to the cardiac region of the stomach, such as in the form of an outwardly directed force (FIGS. 65-68). In the illustrated embodiment,body21′″ ofcardiac member14′″ is made from a molded silicone, embeddedweave23′″ of flexible wire, such as Nitinol wire. The weave increases tear resistance and stiffness.Body21′″ may include a proximally raisedportion34 defining a flange.Flange34 is configured to fit against the GE junction. This causes food to be directed through-opening36 inbody21′″ while resisting the food passing betweencardiac surface22′″ and the wall of the stomach. In the illustrated embodiments,body21′″ may be made from a material, such as a type of molded silicone that is substantially transparent to light. This allows thephysician deploying device10 to be able to better visualize placement of the device during its deployment as would be understood by the skilled artisan.

Esophageal member12′″ may apply a tension to the distal esophagus, such as an outwardly directed force over the area ofsurface20′″.Esophageal member12′″ may include acage44′″ and animpervious wall45′″ coveringcage44″.Wall45′″ may be made from molded silicone, which, in the same manner asbody21′″, may be substantially transparent to light to enhance visibility during deployment.Cage44′″ may be made from anelongated member50′″, which, in the illustrated embodiment, is an elastic member, such as Nitinol wire.Member50′″ is formed as an interwoven spiral.Esophageal member12′″ additionally includes acover58 over the proximal end ofcage44′″.Cover58 provides additional flexibility to the distal end ofmember12′″ to further minimize the potential for erosion or ulceration as well as to provide a better engagement with the esophageal wall.

Connector16′″ includes atension member24′″ may pass through opening36 and has adistal extension38bthat gets incorporated intobody21′″ of the cardiac member and aproximal extension38athat gets incorporated intoesophageal member12′″.Tension member24′″ is defined by one or more strands of flexible wire, such as Nitinol wire covered with a molded silicone layer.Proximal extension38aanddistal extension38bare extensions of the wire definingtension member24″. Whileextensions38a,38bare illustrated as woven withweave23′″ andcage44′″, it should be understood that they may also be an extension of thewires defining weave23′″ andcage44′″. Indeed, it is contemplated thatcage44,tension member24, and weave23 may be made from a single strand of flexible wire, such as Nitinol wire. While only onetension member24′″ is illustrated, it would be possible to add a second one that is radially opposite with respect toopening36. The addition of a second such tension member may reduce the likelihood ofcardiac member14′″ being displaced during deployment by resisting torsional forces placed on the cardiac member. This may help to keepesophageal member12′″ andcardiac member14′″ in better alignment, notwithstanding such forces. However, the presence of a second tension member may undesirably impede normal functioning of the pseudo sphincter at the GE junction.

An alternativebariatric device10″″ includes anesophageal member12″″ andcardiac member14″″ (FIGS. 69 and 70).Esophageal member12″″ is similar toesophageal member12′″ except that it includes acover58 distally as well as one proximally.Cardiac member14″″ is similar tocardiac member14″′ except that it includes amesh23″″ of different weave frommesh23′″. In the illustrative embodiment,esophageal member12″″ has a length of 35 mm, a proximal diameter of 25 mm and a distal diameter of 20 mm. It includes aconnector16′″ with atension member24′″ having a length of 17 mm.

While previously described bariatric devices are illustrated as deployed in a recipient of unaltered anatomy, a modified form of such bariatric devices could perform the same function in a stomach that has been altered by surgery, such as bariatric surgery. Thus, the size and shape of the cardiac member, in particular, would be modified to the configuration of the stomach component of the altered anatomy to provide a tension, such as an outward pressure, similar to the bariatric device used with an unaltered anatomy. For example, abariatric device410 is shown having anesophageal member412 having a wall configured to the size and shape of a portion of the esophagus connected by aconnector416 with acardiac member414 having a wall configured to the size and shape of the cardiac region of a stomach that has undergone vertical banded gastroplasty (FIG. 71). A bariatric device510 is shown having anesophageal member512 having a wall configured to the size and shape of a portion of the esophagus connected by a connector516 with acardiac member514 having a wall configured to the size and shape of the cardiac region of a stomach that has undergone a sleeve gastrectomy (FIG. 72). Abariatric device610 is shown having an esophageal member612 having a wall configured to the size and shape of a portion of the esophagus connected by aconnector616 with acardiac member614 having a wall configured to the size and shape of the cardiac region of a stomach that has undergone a duodenal switch (FIG. 73). Abariatric device710 is shown having anesophageal member712 having a wall configured to the size and shape of a portion of the esophagus connected by aconnector716 with acardiac member714 having a wall configured to generally conform to the size and shape of the cardiac region of the proximal pouch of a recipient that has undergone a gastric bypass procedure, also known as a roux-en-y procedure (FIG. 74). Other examples will become apparent to the skilled practitioner. Previously described tethers may be deployed as part ofconnectors416,516,616 and716.

The bariatric devices disclosed herein may be made in whole or in part from bioabsorbable materials or from non-absorbable materials.

The strain exerted by the bariatric device influences the neurohormonal feedback mechanism present at the esophagus and/or stomach to cause weight loss. The strain that influences the neurohormonal feedback mechanism present at the abdominal portion of the esophagus, the esophageal-gastric junction and/or the cardiac portion of the stomach is intended to be relatively consistent over as large an area as reasonably possible. In contrast to prior proposed devices, such as restriction devices, which require that the recipient ingest food in order to influence neurohormonal feedback mechanisms, the embodiments of the bariatric device disclosed herein are effective in the absence of food. It also augments fullness caused by food.

The tissue attachment, tissue ingrowth and/or mucosal capture, which results from the tissue essentially at least partially incorporating certain embodiments of the bariatric device into the anatomy of the recipient, may provide resistance to the formation of microbial biofilm and thereby reduces the potential for infection, odor, and the like. As with all fixation techniques described herein, these may be used in combination with other fixation techniques. These anchoring techniques may be used to promote long-term deployment by incorporating the device into the body of the recipient.

Although various embodiments are illustrated herein, it should be understood that the features disclosed in each embodiment may be combined as would be apparent to the skilled artisan. In addition to influencing a neurohormonal feedback mechanism of the recipient to cause weight loss, the bariatric devices embodied herein may be capable of being anchored to the recipient and being retained in place for an extended period of time. Moreover, the various embodiments of the bariatric device, once deployed, are of a size and shape that would resist entering the pylorus should the bariatric device distally migrate outside of the esophagus into the stomach or are sufficiently small to pass through the intestines. This reduces the risk to the recipient. The recipient would likely be aware of the distal migration of the device because the recipient would, once again, experience increased hunger as a result of a reduction in satiety and/or metabolism. The physician could then insert an overtube in the recipient and reposition the bariatric device as previously described. Thus, it is unlikely that the bariatric device would migrate without notice and, would unlikely harm the recipient should the device migrate.

The embodiments of a bariatric device disclosed herein can be used for weight control in animals as well as humans. It can be used for weight control in children and adolescents as well as adults. It can be used with overweight and mildly obese recipients as well as with morbidly obese recipients.

Thus, it is seen that the disclosed embodiment provides a new category of weight loss techniques. The embodiment advantageously utilizes mechanoreceptors, such as tension receptors, stretch receptors and/or baroreceptors, such as those located at the abdominal portion of the esophagus and/or esophageal-gastric junction and/or the cardiac portion of the stomach of the recipient to cause weight loss. The disclosed embodiments provide a non-invasive or minimally invasive technique. The disclosed embodiments facilitate burping and vomiting and do not substantially interfere with other functions of the GE junction pseudo-sphincter.

Changes and modifications in the specifically described embodiments can be carried out without departing from the principles of the invention which is intended to be limited only by the scope of the appended claims, as interpreted according to the principles of patent law including the doctrine of equivalents.

Claims (23)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:

1. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach by proximately withdrawing the deployment device to pull the cardiac member against the cardiac portion of the stomach; and

further deploying the bariatric device from the deployment device in the esophagus.

2. The method as claimed inclaim 1, including guiding the deployment device transorally into the stomach via a guide wire.

3. The method as claimed inclaim 1, wherein the deployment device comprises a tubular member having a cross section configured to be smaller than the recipient's esophagus.

4. The method as claimed inclaim 3, wherein, prior to guiding the deployment device to the stomach, the bariatric device is compressed within the tubular member of the deployment device.

5. The method as claimed inclaim 4, wherein deploying the bariatric device in the stomach includes unfurling the cardiac member from the tubular member.

6. The method as claimed inclaim 4, wherein the cardiac member unfolds from a compressed state to an expanded state when the cardiac member is clear from the distal end portion of the tubular member.

7. The method as claimed inclaim 3, wherein the further deploying the bariatric device includes unfurling the esophageal member from the tubular member.

8. The method as claimed inclaim 1, wherein the bariatric device is at least partially deployed from the distal end portion of the deployment device in the stomach utilizing a pusher inserted within the deployment device.

9. The method as claimed inclaim 1, further including deploying the esophageal member in the esophagus.

10. The method as claimed inclaim 1, wherein after deploying the cardiac member in the stomach, the deployment device is withdrawn proximally to position the cardiac member against the cardiac portion of the stomach.

11. The method as claimed inclaim 1, wherein the deployment device is withdrawn proximally to deploy the esophageal member from the deployment device.

12. The method as claimed inclaim 1, wherein prior to deploying the esophageal member, the cardiac member is oriented in the stomach by rotating the deployment device.

13. The method as claimed inclaim 12, wherein the cardiac member is oriented in the stomach by visualizing a marker on the deployment device.

14. The method as claimed inclaim 12, wherein the cardiac member is oriented in the stomach utilizing fluoroscopy.

15. The method as claimed inclaim 1 including anchoring the bariatric device to the recipient after deploying the bariatric device.

16. The method as claimed inclaim 15, wherein the recipient includes a gastro-esophageal junction pseudo-sphincter between the esophagus and the stomach and wherein said anchoring comprises passing at least one tether through the esophageal member, outside of the gastro-esophageal junction pseudo-sphincter through the walls of the esophagus and stomach and through the cardiac member.

17. The method as claimed inclaim 15, wherein said anchoring comprises growing tissue in openings in the bariatric device.

18. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach; and

further deploying the bariatric device from the deployment device in the esophagus, wherein the deployment device comprises a tubular member and wherein the bariatric device is folded into the tubular member with the cardiac member rolled and the esophageal member radially compressed.

19. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach;

further deploying the bariatric device from the deployment device in the esophagus; and

causing strain to be applied by the cardiac member to the cardiac portion of the stomach in the absence of food, including anchoring the esophageal member to the esophagus of the recipient to resist distal migration of the esophageal member with respect to the esophagus, wherein the connector transmits force between the esophageal member and the cardiac member.

20. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach;

further deploying the bariatric device from the deployment device in the esophagus; and

positioning the cardiac member with respect to the cardiac portion of the stomach with at least one line extending outside of the recipient from the bariatric device, wherein at least one line comprises suture material.

21. The method as claimed inclaim 20, including removing at least one line after said positioning.

22. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach;

further deploying the bariatric device from the deployment device in the esophagus; and

positioning the cardiac member with respect to the cardiac portion of the stomach with at least one line extending outside of the recipient from the bariatric device, wherein said at least one line is attached to the esophageal member and is used to snug the cardiac member against the cardiac portion of the stomach.

23. A method of deploying a bariatric device in a recipient having an esophagus and a stomach, the bariatric device having an esophageal member that is configured to generally conform to the shape and size of a portion of the esophagus, a cardiac member that is configured to generally conform to the shape and size of a cardiac portion of the stomach, and a connector connected with the esophageal member and the cardiac member, said method comprising:

guiding a distal end portion of a deployment device to the stomach, wherein at least a portion of the bariatric device is disposed at the distal end portion;

at least partially deploying the bariatric device including the cardiac member from the deployment device in the stomach;

positioning the cardiac member of the bariatric device against the cardiac portion of the stomach;

further deploying the bariatric device from the deployment device in the esophagus; and

positioning the cardiac member with respect to the cardiac portion of the stomach with at least one line extending outside of the recipient from the bariatric device, wherein said at least one line is attached to cardiac member and is used to laterally adjust the cardiac member.

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